Biotech Alert: Searches spiking for these stocks today

These names in the biotech sector are seeing a substantial increase in search activity today, as determined by InvestingChannel. They include: 

• Iterum Therapeutics (ITRM), 2,631% surge in interest
• Arcus Biosciences (RCUS), 735% surge in interest
• Fibrogen (FGEN), 588% surge in interest
• Fate Therapeutics (FATE), 445% surge in interest
• Genprex (GNPX), 425% surge in interest
• Aileron Therapeutics (ALRN), 400% surge in interest
• NovaBay Pharmaceuticals (NBY), 333% surge in interest
• Palatin Technologies (PTN), 318% surge in interest
• Arbutus Biopharma (ABUS), 286% surge in interest
• Adaptimmune (ADAP), 242% surge in interest

Pipeline and key clinical candidates for these companies:

Iterum Therapeutics is dedicated to developing differentiated anti-infectives aimed at combating multi-drug resistant pathogens to improve the lives of people affected by related diseases. Iterum is currently advancing its first compound, sulopenem, a novel penem anti-infective compound, in Phase 3 clinical development with an oral formulation. Sulopenem also has an IV formulation. Iterum has received Qualified Infectious Disease Product and Fast Track designations for its oral and IV formulations of sulopenem in seven indications.

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis, HIF-2a, CD39 and AXL.

FibroGen is “committed to leveraging its expertise in connective tissue growth factor biology and hypoxia-inducible factor to discovering, developing, and commercializing a pipeline of first-in-class therapeutics for the treatment of unmet needs.” Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis, or IPF, locally advanced unresectable pancreatic cancer, metastatic pancreatic cancer, and Duchenne muscular dystrophy, or DMD. Roxadustat is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes, or MDS, and in Phase 3 clinical development in China for treatment of chemotherapy-induced anemia, or CIA.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell-derived cellular immunotherapies to patients with cancer and autoimmune disorders. Using its proprietary iPSC product platform, “the company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products,” the company states.

Genprex is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. The company’s lead product candidate, Reqorsa Immunogene Therapy, is being evaluated in three clinical trials as a treatment for NSCLC and SCLC. Each of Genprex’s three lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex’s SCLC program has received an FDA Orphan Drug Designation. 

Aileron is shifting its disease focus to advancing a pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Aileron’s lead product candidate, LTI-03, is in a Phase 1b clinical trial for the treatment of idiopathic pulmonary fibrosis. LTI-03 is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. Aileron’s second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and EU and Fast Track Designation in the U.S.

NovaBay Pharmaceuticals develops and sells eyecare and skincare products. NovaBay’s leading product, Avenova Antimicrobial Lid & Lash Solution, is often prescribed by eyecare professionals for blepharitis and dry-eye disease and is also available directly to eyecare consumers through online distribution channels such as Amazon.

Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. “Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential,” the company says.

Arbutus Biopharma is a clinical-stage biopharmaceutical company leveraging its extensive virology expertise to identify and develop novel therapeutics with distinct mechanisms of action, which can be combined to provide a functional cure for patients with chronic hepatitis B virus (cHBV). The company’s pipeline of internally developed, proprietary compounds includes an RNAi therapeutic, imdusiran (AB-729) and an oral PD-L1 inhibitor, AB-101. Imdusiran has generated meaningful clinical data demonstrating an impact on both surface antigen reduction and reawakening of the HBV-specific immune response. Imdusiran is currently in two Phase 2a combination clinical trials. AB-101 is currently being evaluated in a Phase 1a/1b clinical trial.

Adaptimmune’s drive is to redefine the treatment of some of the most challenging-to-treat solid tumors. The company’s proprietary cell therapy platform engineers a patient’s own cells to fight cancer. The company’s robust pipeline of cell therapies has the potential to significantly improve the patient’s treatment experience.

Recent news on these stocks:

January 31

Genprex announced that on February 2, the company will implement a 1-for-40 reverse split of its issued and outstanding common stock, par value 0.1c per share. The company’s common stock will trade on a post-split adjusted basis at the beginning of trading on February 2 under the existing trading symbol “GNPX.” As a result of the reverse stock split, every 40 shares of common stock issued and outstanding as of the effective date will be automatically combined into one share of common stock.

Adaptimmune disclosed that the FDA has accepted for priority review the company’s Biologics License Application, or BLA, for afami-cel, an investigational engineered T-cell therapy for advanced synovial sarcoma. The application has a Prescription Drug User Fee Act, or PDUFA, target action date of August 4.

January 30

Iterum Therapeutics announced positive topline results from its REASSURE Phase 3 clinical trial comparing oral sulopenem to oral Augmentin in adult women with uncomplicated urinary tract infections. With the positive data from this trial, Iterum plans to resubmit its New Drug Application for oral sulopenem for the treatment of uUTI in Q2. At the same time, Iterum will focus on selling, licensing, or otherwise disposing of its rights to sulopenem with the goal of maximizing value for its stakeholders. Results demonstrate that oral sulopenem was non-inferior to Augmentin with respect to the trial’s primary endpoint, overall response at the test-of-cure visit in the microbiological-modified-intent-to-treat susceptible population. Oral sulopenem showed overall success in 61.7% of patients compared to 55.0% for Augmentin, demonstrating statistically significant superiority of oral sulopenem versus Augmentin. Both oral sulopenem and Augmentin were well tolerated in this study with discontinuations due to adverse events occurring in less than1% of patients on both regimens. No serious adverse events were reported in patients receiving oral sulopenem, while five SAEs occurred in patients receiving Augmentin, with no drug-related SAEs. The safety profile for oral sulopenem was consistent with those observed in each of the previously conducted Phase 3 trials, with no new safety signals noted beyond those associated with beta-lactams. Iterum expects that the FDA will complete its review and take action six months from the date the FDA receives the resubmitted NDA, or during Q4.

Palatin Technologies announced that it has entered into a definitive agreement with healthcare-focused institutional investors for the issuance and sale of an aggregate of 1.83M shares of its common stock, at a purchase price of $5.46 per share of common stock. Palatin has also agreed to issue in a private placement warrants to purchase up to an aggregate of 1.83M shares of common stock at an exercise price of $5.46 per share. The warrants will become exercisable on the six months anniversary of the closing date and will expire on the date that is four years after the closing date. H.C. Wainwright & Co. is acting as exclusive placement agent for the offering. The closing of the offering is expected to occur on or about February 1, subject to the satisfaction of customary closing conditions. The gross proceeds from the offering are expected to be approximately $10M. Palatin intends to use the net proceeds of this offering for general corporate purposes.

January 29

Gilead (GILD) and Arcus Biosciences announced an amendment to their collaboration agreement and a separate equity investment by Gilead of $320M in Arcus common stock at $21.00 per share. The equity investment and collaboration amendment enable accelerated growth of the companies’ joint development programs that span multiple indications. Additionally, Johanna Mercier, chief commercial officer at Gilead Sciences, will join the Arcus board, bringing Gilead’s total director designees to three. The amendment also includes governance enhancements enabling streamlined decision-making and reflecting the continued growth of the collaboration. Gilead and Arcus have reprioritized the joint domvanalimab development program to focus on advancing and potentially accelerating the Phase 3 studies STAR-121 and STAR-221, which are both expected to be fully enrolled by year-end. This prioritization focuses on domvanalimab-containing regimen research in areas where it may have significant impact in combination with chemotherapy and in settings with high unmet need through all-comer study designs. The companies also plan to initiate STAR-131, a new registrational Phase 3 lung cancer study that includes the domvanalimab plus zimberelimab regimen. This prioritization reflects the companies’ continued conviction in the TIGIT pathway and the Fc-silent design of domvanalimab, which has the potential for differentiation in both efficacy and safety. Additional changes during this prioritization will include discontinuing further enrollment in the Phase 3 ARC-10 study evaluating domvanalimab plus zimberelimab compared to pembrolizumab monotherapy in first-line locally advanced or metastatic, PD-L1-high NSCLC. The discontinuation of the ARC-10 study is based on strategic prioritization to advance and potentially accelerate the Phase 3 studies STAR-121 and STAR-221, which have the potential to address a higher unmet need for patients with lung and gastrointestinal cancers. Gilead and Arcus are grateful to the patients and investigators who have made the choice to participate in ARC-10, which will continue to generate data and insights that will be shared at future scientific conferences. Patients currently enrolled in ARC-10, or who consented prior to January 29 and choose to enroll in the study, may continue their treatment and be monitored according to the study protocol. No changes to the safety and efficacy profile of domvanalimab and zimberelimab have been observed. Also, under the terms of the amended collaboration agreement, the planned Phase 3 first-line study in pancreatic cancer evaluating the investigational small molecule CD73 inhibitor quemliclustat will become an Arcus independent study. Domvanalimab, zimberelimab and quemliclustat are investigational molecules. Neither Gilead nor Arcus has received approval from any regulatory authority for any use of these molecules, and their safety and efficacy for the treatment of lung, gastrointestinal and pancreatic cancers have not been established.

January 25

FibroGen announced graduation and completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network’s, PanCAN, Precision Promise Phase 2/3 adaptive platform trial, which evaluates pamrevlumab in combination with the chemotherapy treatments gemcitabine and nab-paclitaxel for patients with metastatic pancreatic ductal adenocarcinoma, mPDAC. Topline data from this registration study is anticipated in the second quarter of 2024. Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified greater than or equal to 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial, and thus graduated to the second and final Stage of the trial in the third quarter of 2022. Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial. The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024. “We are excited to announce the achievement of this significant milestone in Precision Promise. The graduation and completion of the pamrevlumab arm of this study brings a potential new therapy one step closer for patients with metastatic pancreatic cancer, an underserved population with limited treatment options,” said Thane Wettig, Chief Executive Officer, FibroGen. “We look forward to continuing to work with PanCAN in sharing the topline data in the coming months.”

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About “Biotech Alert”

The Fly will report on a selection of biotech stocks seeing a surge in interest from retail and financial professional investors, based on data from InvestingChannel.

This Fly exclusive recap reveals the biotech stocks that are seeing a spike in searches among the 20-plus million retail and financial professional investors through InvestingChannel’s online financial news media ecosystem.

This increased attention from the investors may be in response to, or advance of, outsized moves for stocks in the biotech sector, which tend to be volatile and prone to sharp swings in share price around binary events such as clinical study results and FDA approvals.